"We will be living this nightmare for ages to come. It's something probably we will never really be able to get closure because it was just such a useless thing that happened to my husband," Joyce Lovelace told a public hearing of the House Energy and Commerce Committee at the Capitol Wednesday.
"I want them to know -- whoever is responsible -- their lack of attention to their duties cost my husband his life, cost my family, cost them a loss that we'll never recover from," Lovelace said.
Rep. Ed Whitfield, R-Ky., chairman of the Energy and Power Subcommittee, introduced Lovelace, the wife of the late Judge Eddie C. Lovelace of Albany, Ky. -- the first confirmed death as a result of fungal contamination from steroid injections produced at the New England Compounding Center.
The compounding pharmacy in Framingham, Mass., produced about 17,000 doses of the injectable steroid methylprednisolone acetate of which some 14,000 doses were used to treat back and joint pain linked to 448 cases of meningitis and infection, killing 32.
Lovelace said her husband was healthy and his only illnesses were allergies and kidney stones. He had two years left in his term as circuit judge.
"When his term was up, he planned to enter into practice with our granddaughter, who is also a lawyer," Lovelace said. "At the end of March he was in a traffic accident, which injured his lumbar and cervical spine. He had gone through the physical therapy and done everything the doctors had told him to do in an effort to get better, to be able to get back on the job."
He had a physical examination just two weeks before he fell so sick on Sept. 11, and the doctors found nothing wrong. On Sept. 11, he had numbness in his hand, a bad headache, two fingers were not right, he fell twice and when he said his legs didn't work he relented and went to the emergency room, Lovelace said.
"They did a CT scan there and it didn't show anything, but based on his symptoms, they transferred him to Vanderbilt [University Medical Center] in Nashville, where he declined rapidly," Lovelace said. "His speech was slurred. He had no grip in his left hand, he could not move his left foot, he had no eye-hand coordination, he could not feed himself. It was -- it was a nightmare to see this man, who was perfectly healthy one moment and then just so quickly go downhill. On [Sept.] 17, he passed away."
Rep. Diana DeGette, D-Colo., said Congress needs to clarify the Food, Drug and Cosmetic Act, which "limits the U.S. Food and Drug Administration's jurisdiction over compounding pharmacies."
"We need to make sure that for these large pharmacies have the ability to act and to act quickly on behalf of patients. In 2011, the Colorado State Board of Pharmacy determined that the New England Compounding Center was distributing unlicensed and unregistered drugs in the state and issued a cease and desist order," DeGette said at the hearing.
"But this was not all the Colorado officials could do, and it was not enough to stop NECC's action. Colorado officials notified the Massachusetts Board of Pharmacy and Massachusetts did nothing," DeGette said. "The Colorado Board of Pharmacy did the right thing, but the system failed. NECC did not improve its operation. The FDA did not act, and Massachusetts did not act."
FDA inspectors and officials were repeatedly informed of problems at NECC, but the strongest action taken by the FDA was a warning letter sent to the company in 2006, a letter that appeared to have very little effect, DeGette said.
"The FDA tells us that they were hobbled by questions about whether they had the legal authority to address the problems at the NECC," DeGette said. "If this is true this is a problem that demands this full committee's immediate attention."
Rep. Ed Markey, D-Mass., and a member of the Energy & Commerce Committee, said he prepared a report for today's hearing that said NECC was no stranger to federal and state regulators.
"It had been the subject of eerily similar safety complaints in 1999, 2001 and 2002, yet in 2002, NECC owner Barry Cadden was appointed to the state's task force charged with developing new regulations for compounding pharmacies. And in June of 2006, the state board waived sanctions," Markey said at the hearing.
Cadden Wednesday refused to testify, citing his Fifth Amendment rights.
Markey's report, "Compounding Pharmacies, Compounding Risk" describes the nature of regulatory oversight and gaps in legal authority that, even before the current meningitis outbreak, led to at least 23 deaths and 86 serious illnesses or injuries in at least 34 states.
The violations included compounding pharmacies selling copies of commercially available drugs, selling drugs made using ingredients that were not FDA-approved or were recalled for safety or effectiveness reasons, cases where sterile facilities were visibly dirty and contamination of the drug product was known to have occurred and either selling drug products without a valid prescription or manufacturing large quantities of drug products, the report said.
The report also said the state Boards of Pharmacy do not typically and consistently oversee the safety of the drugs made by compounding pharmacies.
"The risks of allowing the safety of compounding pharmacies to go largely unregulated have been recognized for years. But a patchwork of state regulation, incomplete and often inaccessible information by compounding pharmacies as well as the industry efforts to thwart better government oversight have complicated efforts to understand the true scope of this problem," Markey said.
"The tragedy of NECC is clearly just the tip of an industry iceberg that has long needed reform and federal oversight. This tragedy demands the strongest response from Congress, federal and state authorities to ensure safeguards are in place to protect patients."
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